Elekta recalled the Leksell GammaPlan Radionuclide RT Treatment Planning System on December 12, 2025. The software, used for treatment planning, may incorrectly irradiate patient locations due to a stereotactic reference error. This recall affects users worldwide, including in the U.S. and various international locations.
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Elekta, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall involves the Leksell GammaPlan Radionuclide RT Treatment Planning System, Software Version 11.1. The device is used for Leksell Gamma Knife treatment planning. The software is distributed worldwide including all U.S. states.
An error in the software can lead to users failing to change an obsolete reference, potentially resulting in incorrect patient irradiation. This poses a serious health risk if the error goes undetected.
No specific incidents or injuries have been reported yet, but the potential for significant harm exists if the error is not identified.
Stop using the Leksell GammaPlan software immediately. Follow the recall instructions provided by Elekta, Inc. and contact your healthcare provider for further guidance.
For more information, contact Elekta, Inc. at [phone number not provided] or visit their website at [website not provided]. Additional details can be found at the FDA link.
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